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Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501) (TRAFIC)

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ClinicalTrials.gov Identifier: NCT01254318
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
McGill University Health Center
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.

Condition or disease Intervention/treatment
Mycoses Leukemia Other: Standard Care

Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)
Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Participants at high risk for IFI
Participants will be considered high risk if they are undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation.
Other: Standard Care
Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.



Primary Outcome Measures :
  1. Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution [ Time Frame: 365 days ]
    Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.


Secondary Outcome Measures :
  1. Percentage of Participants With a Specific Fungal Pathogen at a Single Institution [ Time Frame: 365 days ]
    Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.

  2. Percentage of Participants With Invasive Fungal Infections in Canada [ Time Frame: 365 days ]
    Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants at high risk for IFI at medical institutions in Canada
Criteria

Inclusion Criteria:

  • To be eligible for study inclusion, the participant must have:
  • A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant

Exclusion Criteria:

  • The participant is not eligible for study inclusion if:
  • Their IFI is not related to hematological malignancies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254318


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
McGill University Health Center
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01254318     History of Changes
Other Study ID Numbers: P07501
MK-5592-071 ( Other Identifier: Merck Protocol Number )
First Posted: December 6, 2010    Key Record Dates
Results First Posted: November 2, 2016
Last Update Posted: November 2, 2016
Last Verified: September 2016

Keywords provided by Merck Sharp & Dohme Corp.:
hematological malignancy
fungal infection
leukemia

Additional relevant MeSH terms:
Infection
Mycoses
Hematologic Diseases